GAMMA 3525-1280SRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07613252274247), received between May 6, 2021 and May 6, 2021 — classified as 1 injury.

The most frequently reported specific device problem is “Fracture” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryMay 6, 2021Fracture; Fracture

  THE FOLLOWING WAS REPORTED: "THE SURGEON OPERATED ON A (B)(6) YEAR OLD PATIENT 4 MONTHS AGO. THE OPERATION WENT WELL AS WELL AS THE POST-OP CHECK-UP. THE PATIENT DID NOT EXPRESS ANY DISCOMFORT AND WAS ABLE TO BE TAKEN CARE OF FOR 48 HOURS POST-OP. THE PATIENT RETURNED TO DR. L TO REPORT PAIN IN HER HIP. THE PATIENT INDICATED THAT SHE HAD NOT FALLEN AND HAD NOT RECEIVED A SHOCK TO THE IMPLANT. DR. L PERFORMED A CHECKUP AND NOTICED THAT THE GAMMA 3 NAIL HAD BROKEN OFF COMPLETELY ABOVE THE NECK SCREW. THE SURGEON REMOVED THE IMPLANT AND PLACED A NEW ONE (SAME SIZE AS THE PREVIOUS ONE) ON (B)(6) 2021. THE REMOVAL AND INSERTION WENT WELL.

  Patient problems: Failure of Implant; Implant Pain

  MAUDE report 11784708 ↗